Holder and packaging for a hardened medicated matrix

ABSTRACT

A stick-like holder and packaging, including an overcap and a sealed, light, moisture and tamper resistant foil pouch, for a hardened, medicated matrix affixed to one end of the holder including detent means for releaseably mounting the overcap on the matrix end of the holder and with the holder having a flat, label receiving handle at its other end and a flange to prevent swallowing of the holder when placed in a patient&#39;s mouth to medicate or pre-medicate the patient.

This is a division of application Ser. No. 07/776,543, filed Oct. 11,1991, now U.S. Pat. No. 5,296,234.

A recent development in the health care field, particularly related tothe administration of medication, is the formulation of some medicationsin a pleasant-tasting hardened matrix. The desired dosage can accuratelybe controlled and accounted for and there is no likelihood of spillage,as when administering liquid medications to babies, children and elderlypersons, whereupon the dosage received may be less than the dosageprescribed.

This medicated matrix may be formed on the end of a stick to provide aproduct which is particularly well-adapted for administrating certainmedications to elderly persons and others who are emaciated and weakenedby their illnesses and who, therefore, are often very difficult tomedicate by injection or even orally as they often have difficulty inswallowing pills and the like. Likewise, such a product is a natural foradministering medications to young people and children.

One hardened, sucrose based, medicated matrix product of the typediscussed hereinbefore is disclosed in U.S. Pat. No. 4,671,953 which isincorporated herein by reference. Whereas the foregoing U.S. Pat. No.4,671,953 discusses use of a simple stick upon which the medicatedmatrix may be formed, no specific stick structure or packagingarrangement is shown or described.

SUMMARY OF THE INVENTION

The present invention is directed to a new, novel and improvedstick-like holder for such products having safety and other features notpreviously disclosed and also to a new and novel pack-up or packagingarrangement for such products.

This product, which is characterized, in part, by a sucrose basedhardened matrix containing a dosage of medication, such as fentanylcitrate, which is mounted on the end of an elongated stick-like holderhaving a handle portion at its opposite end, provides a non-invasivemeans for achieving analgesia, sedation and relief from anxiety throughtransmuscosal absorbtion of the prescribed medication interspersedthrough the aforesaid hardened, pleasant-tasting "matrix on a stick"when same is placed in the mouth. It is particularly useful as apremedication before anesthesia, before a painful diagnostic procedure,for emergency room pain management, for post-operative pain control,etc.

The matrix holder has a comfortable handle which is also adapted toreceive a pressure sensitive label carrying important information as tothe medication dispersed through the matrix and is of a proper length sothat the matrix end can comfortably reach the buchal pouch area of themouth. Further, the handle is molded of a suitable plastic which hasenough flexibility that it wouldn't splinter or crack if the patientshould fall with the handle in his or her mouth. Another safety featureof the holder is an integral flange adjacent the handle which insuresagainst the holder being swallowed.

The plastic overcap, which is an important part of the novel packagingarrangement, is in the form of a tubular member having a closed end andan open end for receiving therein the matrix-bearing end of theelongated handle. Detent means are provided for retaining the overcap onthe handle during shelf storage and/or transporting of the product,between intermittent uses of same by the same patient, and to dispose ofthe unused portions of the product, particularly if the matrixmedicament should be a "controlled substance". Although generallytubular or cylindrical, the overcap is provided with rib means whichprevent free rolling of the matrix holder/overcap assembly when placedon a flat surface, as off a table or countertop.

Another part of the packaging arrangement is a foil pouch in which thematrix holder/overcap assembly is sealed, the laminated foil pouch beinglight, vapor, moisture, and tamper resistant. The pouch, which can alsobe labeled, cushions and provides good shelf life for the matrixholder/overcap subassembly.

An object of the present invention is to provide a new and improvedstick-like holder for a hardened medicated matrix to be placed in apatient's mouth and a novel packaging arrangement therefor including onovercap and a foil pouch.

This and other objects and features of the present invention will becomemore fully apparent from the following description and appended claimstaken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is perspective view of an interengaged stick-like medicatedmatrix holder and an overcap therefor embodying a preferred embodimentof the invention;

FIG. 2 is a side elevational view of the stick-like holder shown in FIG.1 with the medicated matrix shown in broken line;

FIG. 3 is a left end elevational view thereof;

FIG. 4 is a right end elevational view thereof;

FIG. 5 is a top plan view thereof;

FIG. 6 is an enlarged fragmentary view of the matrix supporting end ofthe stick-like holder as circled in FIG. 5;

FIG. 7 is a side elevational view of the overcap shown in FIG. 1;

FIG. 8 is a left end elevational view thereof;

FIG. 9 is a right end elevational view thereof;

FIG. 10 is a longitudinal sectional view thereof taken generally alongline 10--10 of FIG. 7;

FIG. 11 is an enlarged fragmentary sectional view thereof takengenerally along line 11--11 of FIG. 9;

FIG. 12 is a side elevational view showing the beginning of the assemblyof the overcap over the matrix-bearing end of the stick-like holder;

FIG. 13 is a perspective view illustrating a preferred embodiment of thepackaging arrangement of the present invention including sealing receiptof the matrix holder/overcap assembly into the foil pouch and packing ofseveral of the sealed pouches into a carton; and

FIG. 14 is a fragmentary sectional view showing the detentinterengagement means between the matrix holder and the overcap.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings, a preferred embodiment of a portion ofthe invention is shown in FIG. 1 in the form of an assembly orinterengagement16 of a stick-like holder 18 having a hardened, sucrosebased medicated matrix 26 affixed to one end 24 thereof with aprotective overcap 20. The stick-like holder 18 which is formed of asuitable plastic as a one-piece elongated element by an injectionmolding process, for instance, is characterized by a relatively thin,cylindrical rod-like member 22 having the medicated, butpleasant-tasting, matrix 26 affixed to the one end 24 thereof and ahandle 28 at its opposite end. The handle 28 is flat for comfortablegripping and the length of the holder 18 is such that the medicatedmatrix 26 can easily be inserted into the patient's mouth and into thebuchal pouch portion thereof for most effective transmucosal absorbtionof the medicament interspersed though the hardened matrix 26. As isillustrated in FIG. 2, the opposite side edges of the handle 28 areprovided, adjacent a circular flange 32 on the holder 18, with cut-awayportions 29.

As previously noted herein, the medicated matrix 26 is particularly wellsuited as a premedication before anesthesia, before a painful diagnosticprocedure, for emergency room pain management, for post-operative paincontrol, etc., thus providing a non-invasive procedure for achievinganalgesia, sedation and relief from anxiety. As noted in U.S. Pat. No.4,671,953 which is incorporated herein by reference, one suitablemedicament for the medicated matrix 26 would be fentanyl citrate. Apressure sensitive mylar label 30 bearing informative data as to themedicated matrix 26 may be applied to one or both sides of the flathandle28. As illustrated in FIG. 6, the matrix-bearing end 24 of thestick-like holder 18 is gently tapered toward a rounded end thereof andis provided with a longitudinally spaced series of annular roundedgrooves 34 which serve to effectively affix the medicated matrix 26thereto.

The elongated holder 18 is formed of a sufficiently flexible plasticthat should a patient fall with the holder 18 in his or her mouth, theholder 18 will not splinter or crack. Another safety feature is thecircular flange 32 which is integrally formed on the elongated holder 18normally thereto and adjacent the cut-away portions 29 of the flathandle 28. This circular flange 32 prevents a patient from swallowingthe elongated holder18 and serves further purposes which will bedescribed hereinafter.

The overcap 20, which may also be injection molded, is formed of plasticand is characterized by a generally tubular body portion 36 having aclosed end 38 and an open end 40. The body portion 36 tapers slightlyoutwardly from the closed end 38 toward the open end 40 to facilitateremoval of same from its mold. The open end 40 is provided with agenerally cylindrical end portion or collar 42 which is defined by anoutwardly projecting annular flange portion 44 and a cylindrical wallportion 46 which extends in an axial direction away from the closed end38at a right angle from the outer edge of said annular flange portion44. Theinner diameter of the cylindrical end portion 42 is slightlygreater than the diameter of the circular flange 32 provided on theelongated holder 18. A series of four retaining bumps 48 are provided onthe inner surface of the cylindrical end portion 42 in circumferentiallyspaced relationshipand serve as part of detent means for releaseablyinterengaging the elongated matrix bearing holder 18 with the overcap20, the other part of the detent means being the circular flange 32 onthe elongated holder 18. The detent means is best illustrated in FIG. 14which shows the edge of the circular flange 32 after same has beenresiliently snapped past the retaining bumps 48 upon inserting thematrix bearing end 24 of the holder 18 into the open end 40 of theovercap 20, as shown in FIG. 12. Inward movement of the elongated holder18 into the overcap 20, to prevent engagement of the medicated matrix 26with the closed end 38 of the overcap 20, is limited by an integralconcentric annular wall structure 50which is disposed within thecylindrical end portion 42 with its outermost edge 52 being spacedinwardly of the outer edge of the cylindrical wall portion 46 andgenerally in alignment with the innermost portions of the retainingbumps 48. As shown in FIG. 14, once the circular flange 32 has beensnapped over the retaining bumps 48 to releaseably interengage thematrix bearing holder 18 in the overcap 20, the flange 32 engages theannular wall structure 50 to limit further inward movement of the matrixbearing end 24 of the holder 18. The diameter of the annular wallstructure 50 is less than that of the cylindrical wall portion 46 andthe wall structure 50 generally defines an extension of the tubular bodyportion 36 of the overcap 20 longitudinally beyond the annular flange44. The aforesaid structure of the collar 42 provides sufficientflexibility of the cylindrical wall portion 46 for effective operationof the detent means and insures that the holder 18 is always heldtightly in the overcap20 and doesn't rattle even if the tolerances arenot met exactly.

The outer surface of the cylindrical end portion 46 and the adjacentouter surface of the tubular body portion 36 of the overcap 20 areprovided witha circumferentially spaced series of four longitudinallydisposed ribs 54. Should the interengaged holder 18 and overcap 20 belaid down on a flat surface such as a table or countertop, the ribs 54prevent free rolling ofthe holder/overcap assembly 16 onto the floor,any rolling would be limitedto less than 90°. So as to not detrimentallyeffect the aforesaid flexibility of the cylindrical wall portion 46, theribs 54 are disposed between the retaining bumps 48 rather than inangular alignment therewith.

The preferred embodiment of the packaging arrangement further includes,as illustrated in FIG. 13, a laminated foil pouch 56 in which theholder/overcap assembly 16 is sealed prior to placing several of suchsealed pouches 56 in a carton 58. The foil pouches 56 serve to cushionthehandle/overcap assemblies 16 and, as the pouches 56 are light,moisture, and vapor proof, also provide good shelf life. The very natureof the pouches 56 provides clear evidence of any tampering therewith.Although not specifically illustrated, the pouches 56 may be imprintedwith pertinent data or preprinted pressure sensitive labels may beapplied thereto.

With reference again to the overcap 20, it is noted that same is veryconvenient for storing the matrix bearing holder 18 during intermittentuse thereof by a patient and for return of an unused portion thereof toa hospital pharmacy, particularly if the medicament in the matrix 26 isa "controlled substance".

The one-piece elongated plastic holder 18 having a pleasant-tasting,hardened medicated matrix 26 affixed to one end thereof provides anon-invasive drug delivery means which is especially well-adapted forpre-medicating children and elderly patients, a safety flange 32 beingprovided so that the matrix bearing holder 18 can not be accidentallyswallowed. When medicating a patient, the physician can observe when thedesired anesthesia, sedative or analgesia effect has been achieved, atwhich point the matrix bearing holder 18 can be removed from patient'smouth. Further, more responsive patient's can use this drug deliveryproduct to self-administer medication and thus to self-manage their veryindividual pain experience.

While there has been shown and described a preferred embodiment of theinvention, it will be obvious to those skilled in the art that changesandmodifications may be made without departing from the invention, andit is intended by the appended claims to cover all such changes andmodifications as fall within the true spirit and scope of thisinvention.

We claim:
 1. A protective overcap for a stick holder having a hardenedmedicated matrix affixed to a first end portion of the stick holder,said protective overcap comprising a tubular plastic member having afirst, closed end and a second, open end opposite said first end, saidprotective overcap constructed to be fit over the first end portion ofthe stick holder having a hardened, medicated matrix affixed thereto,and a detent mounted on said protective overcap proximate said second,open end of said protective overcap said detent being constructed tolimit movement of the stick holder within said protective overcap and toretain releasably the first end portion of the stick holder within saidprotective overcap.
 2. A protective overcap in accordance with claim 1,wherein said second open end of said protective overcap is substantiallycylindrical, and wherein a plurality of longitudinally-oriented ribs areformed on an exterior surface of said protective overcap proximate saidsecond, open end of said protective overcap, said plurality oflongitudinally-oriented ribs having a capacity to deter free rolling ofsaid protective overcap when said protective overcap is placed on asmooth surface.
 3. A protective overcap in accordance with claim 1,wherein said protective overcap further comprises a wall formed on aninterior surface of said protective overcap between said first, closedend and said detent, said wall positioned proximate to and spaced fromsaid detent, said wall being constructed to engage a circular flangeportion on the stick holder after the circular flange portion has beenforced past said detent, said wall being constructed to prevent furthermovement of the stick holder toward said first, closed end of theprotective overcap when the circular flange portion is in contact withsaid wall, thereby preventing engagement between said first, closed endof said protective overcap and the hardened, medicated matrix affixed tothe first end portion of the stick holder.
 4. A package for a hardened,medicated matrix affixed to a first end portion of a stick holder, saidpackage comprising a tubular overcap constructed of a plastic material,said overcap having a first, closed end and a second, open end oppositesaid first end, said overcap constructed to be fit over the first endportion of the stick holder having a hardened, medicated matrix affixedthereto, and a detent mounted on said overcap proximate said second,open end of said overcap, said detent being constructed to limitmovement of the stick holder within said overcap and to retainreleasably the first end portion of the stick holder within saidovercap.
 5. A package in accordance with claim 4, wherein said second,open end of said overcap is substantially cylindrical, and wherein aplurality of longitudinally-oriented ribs are formed on an exteriorsurface of said overcap, said plurality of longitudinally-oriented ribshaving a capacity to deter free rolling of said overcap when saidovercap is placed on a smooth surface.
 6. A package in accordance withclaim 4, wherein said overcap further comprises a wall formed on aninterior surface of said overcap between said first, closed end and saiddetent, said wall positioned proximate to and spaced from said detent,said wall being constructed to engage a circular flange portion providedon the stick holder after the circular flange portion has been forcedpast said detent, said wall being constructed to prevent furthermovement of the stick holder toward said first, closed end of theprotective overcap when the circular flange is in contact with saidwall, thereby preventing engagement between said first, closed end ofsaid overcap and the hardened, medicated matrix affixed to the first endportion of the stick holder.